Medication adherence apparatus and methods of use

ABSTRACT

Provided herein are systems, methods and apparatuses for a medication adherence apparatus and methods of use. A method of adhering to medical prescription requirements combines sensors and hardware to record a cap state including an orientation, temperature, time stamp, and location of a cap device to enhance a patient&#39;s adherence to medical prescription when operably coupled with a computing device.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is a continuation from and claims priority toPCT application serial no. PCT/US19/55596, filed Oct. 10, 2019, whichclaims priority to U.S. provisional application Ser. No. 62/743,964,filed Oct. 10, 2018, each herein incorporated by reference in theirentireties.

BACKGROUND

The invention generally relates to medication adherence.

Outpatient prescription medication treatments are relied upon forincreased quality of life and lower lifetime healthcare costs. Taking atleast 80% of a prescribed drug is required to achieve desiredtherapeutic outcomes and lower lifetime healthcare costs. Outpatientsstrongly desire to avoid such events and hospital stays, yet only 20% ofall outpatients take their prescription medicines according to doctor'sinstructions.

Increased medication adherence, also known as patient adherence,medication adherence, or patient compliance, benefits the healthcaresystem by vastly reducing patients' lifetime medical costs whileincreasing their therapeutic outcomes. Further, patients have a desireto adhere, but will not take on the burden of any additional actions orotherwise change their behavior. The present invention solves theseproblems as well as others.

SUMMARY OF THE INVENTION

Provided herein are systems, methods and apparatuses for a medicationadherence apparatus and methods of use.

The methods, systems, and apparatuses are set forth in part in thedescription which follows, and in part will be obvious from thedescription, or can be learned by practice of the methods, apparatuses,and systems. The advantages of the methods, apparatuses, and systemswill be realized and attained by means of the elements and combinationsparticularly pointed out in the appended claims. It is to be understoodthat both the foregoing general description and the following detaileddescription are exemplary and explanatory only and are not restrictiveof the methods, apparatuses, and systems, as claimed.

BRIEF DESCRIPTION OF THE DRAWINGS

In the accompanying figures, like elements are identified by likereference numerals among the several preferred embodiments of thepresent invention.

FIG. 1 is a perspective view of the medication adherence apparatus.

FIG. 2A is a perspective view of the cap device, according to oneembodiment. FIG. 2B is an exploded view of the cap device, according toone embodiment. FIG. 2C is a cross-sectional view of the cap device,according one embodiment.

FIG. 3A is a perspective bottom view of the main housing; FIG. 3B is atop view of the main housing; FIG. 3C is a cross-sectional view of themain housing; and FIG. 3D is a bottom view of the main housing.

FIG. 4A is a perspective top view of the tube connector; FIG. 4B is aperspective bottom view of the tube connector; FIG. 4C is across-sectional view of the tube connector; FIG. 4D is a top view of thetube connector.

FIG. 5A is a perspective top view of the sensor socket; FIG. 5B is aperspective bottom view of the sensor socket; FIG. 5C is across-sectional view of the sensor socket; FIG. 5D is a top view of thesensor socket.

FIG. 6A is cross-sectional view of the cap device with the main housing,tube connector, and sensor socket; and FIG. 6B is a cross-sectional viewof the cap device showing the tube connector and the sensor socket withthe sensor.

FIG. 7A is a perspective top view of the sensor cover; FIG. 7B is aperspective bottom view of the sensor cover; FIG. 7C is a bottom view ofthe sensor cover.

FIG. 8A is a perspective top view of the sensor cover with the forcesensor and the thermistor proximity connector; FIG. 8B is a perspectivebottom view of the sensor cover with the force sensor and the thermistorproximity connector; FIG. 8C is a side view of the sensor cover with theforce sensor and the thermistor proximity connector; FIG. 8D is a bottomview of the sensor cover with the force sensor.

FIG. 9A is a perspective top view of the PCB cap coupled with thethermistor proximity connector, the force motion unit, the temperaturesensor, and the battery cover; FIG. 9B is a side view of the PCB capcoupled with the thermistor proximity connector, the force motion unit,the temperature sensor, and the battery cover; FIG. 9C is a top view ofthe PCB cap coupled with the thermistor proximity connector, the forcemotion unit, the temperature sensor, and the battery cover.

FIG. 10A is a side view of the accelerometers coupled with the batterycover; FIG. 10B is a top perspective view of the battery andaccelerometers coupled with the battery cover; FIG. 10C is a top view ofthe battery and accelerometers coupled with the battery cover.

FIG. 11A is a perspective top view of the battery cover; FIG. 11B is atop view of the battery cover.

FIG. 12A is a top perspective view of the battery; FIG. 12B is a topview of the battery.

FIG. 13 is a top view of the PCB cap with the printed circuitry.

FIG. 14 is a flow chart of one embodiment of the medication adherencesystem.

FIG. 15A a perspective view of an alternative embodiment of themedication adherence apparatus; FIG. 15B is an exploded view of thefirst cap device and second cap device, according to one embodiment;FIG. 15C is a cross sectional view of the medication adherence apparatusfrom FIG. 15A; FIG. 15D is a perspective bottom view of the firstbattery cover; FIG. 15E is a perspective top view of the second batterycover and the second PCB cap; and FIG. 15F is a perspective top view ofthe second battery cover and the second battery.

FIG. 16A a perspective view of an alternative embodiment of themedication adherence apparatus; FIG. 16B is an exploded view of thefirst cap device and second cap device, according to one embodiment;FIG. 16C is a cross sectional view of the medication adherence apparatusfrom FIG. 16A; FIG. 16D is a perspective bottom view of the firstbattery cover; FIG. 16E is a perspective top view of the second batterycover and the second PCB cap; and FIG. 16F is a perspective top view ofthe second battery cover and the second battery.

FIG. 17A is an exploded view of another embodiment of the medicationadherence apparatus and the components of the third cap device; FIG. 17Bis cross sectional view of the third cap device; FIG. 17C is aperspective view of the battery operably disposed in the first batterycover operably disposed over the PCB; FIG. 17D is a cross-sectional viewof another embodiment of the third cap device; FIG. 17E is a top view ofone embodiment of the proximity sensor; FIG. 17F is a top view ofanother embodiment of the third cap device; FIG. 17G is a bottomperspective view of the first main housing with an alternative proximitysensor.

FIG. 18A is a perspective top view of the first main housing; and FIG.18B is a perspective bottom view of the first main housing.

FIG. 19A is a perspective top view of the first battery cover; and FIG.19B is a perspective bottom view of the first battery cover.

FIG. 20A is a perspective top view of the first spacer cap; and FIG. 20Bis a perspective bottom view of the first spacer cap.

FIG. 21A is a perspective top view of the light pipe; and FIG. 21B is aperspective bottom view of the light pipe.

FIG. 22A is a perspective top view of the PCB; and FIG. 22B is aperspective bottom view of the PCB; FIG. 22C is a perspective top viewof the PCB layout; and FIG. 22D is a perspective bottom view of the PCBlayout; FIG. 22E is a schematic of the PCB layout.

FIG. 23 is a flowchart of the PCB layout.

FIG. 24A is a perspective top view of the bottom stop cap; and FIG. 24Bis a perspective bottom view of the bottom stop cap.

FIG. 25A is a perspective top view of the load cell; and FIG. 25B is aperspective bottom view of the load cell.

FIG. 26A is a perspective top view of the base cap; and FIG. 26B is aperspective bottom view of the base cap.

FIG. 27 is a schematic the medication adherence software application.

DETAILED DESCRIPTION OF THE INVENTION

The foregoing and other features and advantages of the invention areapparent from the following detailed description of exemplaryembodiments, read in conjunction with the accompanying drawings. Thedetailed description and drawings are merely illustrative of theinvention rather than limiting, the scope of the invention being definedby the appended claims and equivalents thereof.

Embodiments of the invention will now be described with reference to theFigures, wherein like numerals reflect like elements throughout. Theterminology used in the description presented herein is not intended tobe interpreted in any limited or restrictive way, simply because it isbeing utilized in conjunction with detailed description of certainspecific embodiments of the invention. Furthermore, embodiments of theinvention may include several novel features, no single one of which issolely responsible for its desirable attributes or which is essential topracticing the invention described herein. The words proximal and distalare applied herein to denote specific ends of components of theinstrument described herein. A proximal end refers to the end of aninstrument nearer to an operator of the instrument when the instrumentis being used. A distal end refers to the end of a component furtherfrom the operator and extending towards the surgical area of a patientand/or the implant.

The use of the terms “a” and “an” and “the” and similar referents in thecontext of describing the invention are to be construed to cover boththe singular and the plural, unless otherwise indicated herein orclearly contradicted by context. It will be further understood that theterms “comprises,” “comprising,” “includes,” and/or “including,” whenused herein, specify the presence of stated features, integers, steps,operations, elements, and/or components, but do not preclude thepresence or addition of one or more other features, integers, steps,operations, elements, components, and/or groups thereof.

Recitation of ranges of values herein are merely intended to serve as ashorthand method of referring individually to each separate valuefalling within the range, unless otherwise indicated herein, and eachseparate value is incorporated into the specification as if it wereindividually recited herein. The word “about,” when accompanying anumerical value, is to be construed as indicating a deviation of up toand inclusive of 10% from the stated numerical value. The use of any andall examples, or exemplary language (“e.g.” or “such as”) providedherein, is intended merely to better illuminate the invention and doesnot pose a limitation on the scope of the invention unless otherwiseclaimed. No language in the specification should be construed asindicating any nonclaimed element as essential to the practice of theinvention.

References to “one embodiment,” “an embodiment,” “example embodiment,”“various embodiments,” etc., may indicate that the embodiment(s) of theinvention so described may include a particular feature, structure, orcharacteristic, but not every embodiment necessarily includes theparticular feature, structure, or characteristic. Further, repeated useof the phrase “in one embodiment,” or “in an exemplary embodiment,” donot necessarily refer to the same embodiment, although they may.

As used herein the term “method” refers to manners, means, techniquesand procedures for accomplishing a given task including, but not limitedto, those manners, means, techniques and procedures either known to, orreadily developed from known manners, means, techniques and proceduresby practitioners of the chemical, pharmacological, biological,biochemical and medical arts. Unless otherwise expressly stated, it isin no way intended that any method or aspect set forth herein beconstrued as requiring that its steps be performed in a specific order.Accordingly, where a method claim does not specifically state in theclaims or descriptions that the steps are to be limited to a specificorder, it is no way intended that an order be inferred, in any respect.This holds for any possible non-express basis for interpretation,including matters of logic with respect to arrangement of steps oroperational flow, plain meaning derived from grammatical organization orpunctuation, or the number or type of aspects described in thespecification.

Generally speaking, the medication adherence apparatus 100 and methodsof use comprise a container element 110 and a cap device 120 including ahardware system, as shown in FIG. 1. The cap device 120 without thecontainer element 110 is shown in FIG. 2A. The container element 110 maybe any container element to house a medication, such as a collapsibletube made of metal or metal lined, made of low-density polyethylene ormade from laminated material, wide-mouthed plastic jar, rigid bottle orjar constructed of glass or polypropylene or a platform developed forstorage, display, and utilization of medicament containers such as atube, pill bottle, balm jar or tray. The medication may be any type ofmedication, either in pill, powder, liquid, or gas form. The cap statecomprises the force or weight of the container element, the orientationof the cap device 120, the temperature of the cap device 120, and thetime stamp including the day, time, and date. The force or weight of thecontainer element 110 is obtained when the container element 110 isinserted into the cap device 120. The temperature inside the mouth ofthe container element 110 is obtained by the cap device 120. Thepresence or absence of the container element 110 in the cap device 120is detected by the cap device 120. The orientation of the cap device 120is detected to determine if the cap device 120 and/or the containerelement 110 is upright, which is generally along the vertical axis 101.And any movements of the cap device 120 may be detected, such as alongthe vertical axis 101, the longitudinal axis 103, or the lateral axis105. The cap device 120 detects the weight of the container element 110and stores or sends an information signal of the weight of the containerelement. The cap device detects the cap state and whether the containerelement is attached or connected to the cap device and stores or sendsthe cap state information signal. The cap device 120 receives amedication schedule and notification parameters to notify a patient byan alarm if medication is missed. The alarm may be an audio sound, avisual notification, an electronic notification, indicators, or a cellphone notification. The cap device records then time of when the patientstarts the adherence (cap device is off the container element) and endsthe adherence (cap device is on the container element), which is usedfor further diagnostics, such as when the patient starts taking it butthen closes up again after about 3 s. Upright is generally along thevertical axis with variations between about 1 and about 5 degrees.

The medication adherence apparatus helps patients adhere to medicalprescription requirements. The medication adherence apparatus comprisesa hardware combining sensors to record cap state including the position,orientation, temperature, time stamp, and location of the cap device andthus enhance patient's adherence to medical prescription when operablycoupled with a mobile device or other computing device. The medicationadherence apparatus can send the compliance information to a mobileapplication or the cloud, and can accessible by the patient and/ordoctor so there is a real-time feedback of his progress of prescriptioncompliance and adjust any prescription behavior accordingly. In oneembodiment, the compliance information is sent to a web serveraccessible by the treating doctor who can objectively monitor patients'compliance. The container element may be any element that holds anddispenses medication. In one embodiment, the container element is a tubethat dispenses topical medication. Medication may be in a lotion form, apill form, a powder form, or liquid form. A medication (also referred toas medicine, pharmaceutical drug, or simply drug) is a drug used todiagnose, cure, treat, or prevent disease.

In general, a mobile device may include any mobile telecommunicationsdevice such as, but not limited to, a mobile (e.g., cellular) phone orequivalent, including an iPhone™, Droid™, or the like. A mobiletelecommunications device typically may include a processor or othercomputing module/device which may include software module, hardware, orthe like, including machine readable code configured to operate thedevice to receive and/or send information from the apparatus describedherein. Such code may be provided with, or separately from, theapparatus described. A mobile telecommunications device may be referredto (and includes) a cell or cellular phone or telephone, a mobile phoneor telephone, a smartphone, smart eye glasses or virtual realityglasses; an handheld computer, tablet, a wearable computer, a wearablesensor, an electronic book reader, electronically-functional jewelry, orthe like. Code may be referred to a software, or application software(“app” or “application”) and may be downloaded from a remote locationonto the mobile telecommunications device.

As shown in FIG. 2B, the cap device 120 comprises a main housing 130, atube connector 140, a sensor socket 150, a sensor cover 160, a connectorthermistor proximity 170, a force sensor unit 180, a memory circuit 190,an accelerometer 200, a temperature sensor 210, a battery 220, a PCB(printed circuit board) or board 230, and a battery cover 240. The tubeconnector 140 may be altered such that different types of containerelements 110 may be coupled with the cap device 120. As shown in FIG.2C, the main housing 130 is operably disposed over the sensor socket 150and the battery cover 240 as to enclose the cap device 120. The tubeconnector 140 is operably coupled with the main housing 130 as to securethe cap device 120 to the container 110 and move axially down thevertical axis 101 in the while sitting on the sensor cover 160. Thetemperature sensor 210 is operably disposed within the tube connectorand the force sensor unit 180 is operably disposed between the sensorcover 160 and the sensor socket 150. The connector thermistor proximity170 is operably coupled through the sensor cover 160 and the sensorsocket 150 to the PCB cap 230. The sensor cover 160 is disposed on theforce sensor unit 180, while the force sensor unit 180 is disposed inthe sensor socket 150. The force sensor unit 180 detects the force orweight of the container element 110 inserted into the cap device 120.

The sensor socket 150 includes a rigid snap connection to the mainhousing 130. The PCB cap 230 is operably coupled with the force sensorunit 180, the connector thermistor proximity 170 and the memory circuit190. The battery 220 is operably disposed in the battery cover 240 andthe accelerometer 200 is operably disposed in the battery cover 240through the PCB cap 230. The temperature sensor 210 detects thetemperature inside the mouth of the container element 110. The connectorthermistor proximity 170 is operably disposed on top of the sensorsocket 150. The connector thermistor proximity sensor senses when thecontainer element 110 is present or absent from the cap device 120. Theaccelerometer 200 detects the orientation of the cap device 120 andregisters when the cap device 120 is upright along vertical axisdirection 101 so the weight can be measured. The accelerometer 200 alsodetects movements of the container element 110 such as twisting capdevice open or close, shaking the container element 110, or tilting ofthe container element 110. Data is stored in the memory circuit 190,which includes a wireless module to communicate the cap stateinformation to a mobile telecommunications device.

In one embodiment, the technology platform for supporting medicationadherence management consists of a smart peripheral sensor device (capdevice) that tracks parameters such as amount of medication dispensed,temperature at medication dispensation, time at medication dispensation;a smartphone application (Mobile Application) for tracking medicationadherence that communicates with the cap device using the BLE dataprotocol; and cloud web servers with a database thereon for storingadherence data (Web System) or server database and which communicateswith Mobile Application for data upload/download.

The Mobile Application can communicate with the cap device using lowpower Bluetooth (BLE) and with the Web System using a WiFi or cellularnetwork. The Mobile Application determines if the patient is taking themedicine based on data from the cap device and produce local alertsbased on protocols established. The Mobile Application executes theestablished protocols and provides additional adherence reportingcapabilities and facilitates surveys of the patient. Mobile Applicationcheck last data sync timestamp with the sensor device for each BLEconnection established and pull in available data from the cap deviceand gathering data. The Mobile Application transits this data back toWeb System, as well as, receives data and parameters from the WebSystem.

The Web System includes web based server code for enabling thepersonalization of system communications through messages and surveysbased on adherence criteria of: whether medication is applied or notapplied; time when medication is applied; quantity of medication appliedduring each dose.

The Mobile Application determines if patient is taking the medicinebased on the cap device/sensor peripherals and produce local alertsbased on protocols established. App provides additional adherencereporting capabilities and facilitates surveys. Mobile app checks lastdata sync timestamp with the sensor device for each BLE connectionestablished and pull in available data from sensor. The mobile apptransits this data back to servers when cellular or other internetconnection is available.

The Web System includes database systems that store the medicationadherence data from a collection of patients, and software code forpredictive algorithms that can predict patient adherence trends from thecollected data, stratify patient behavior based on adherence data andsurvey results, and determine suitable messages to be provided to theMobile Application to improve patient adherence. Data gathered from allpatients is used to model patient behavior with respect to skippingmedications and other non-adherence trends.

The Web System includes an Administrative Web Portal that is used toprovision accounts for Clinical Research Organizations (CROs). The CROsuse this Administrative Web Portal to manage patients participating inthe trial, their medication schedules specific to a trial, setting upsurveys and data reports, and provide medication adherence reporting.

The technology platform includes data security layers across the WebSystem, the Mobile Application and the cap device. Password protectionand encryption of data occurs at every level and provide securecompliances for HIPAA. The web services programs (ApplicationProgrammable Interface) which provide transmission layer for data flowbetween server and mobile have secure HTTPS protocol implemented.

Sensors

The accelerometer may be an orientation sensor, including a gyroscope, amagnetometer or any combination, can be used for sensing the orientationof the cap device 110. For example, fusing the data from accelerometer,gyroscope and magnetometer makes good use of the quick response time andsensitivity of the gyroscope, while the accelerometer and themagnetometer can correct the gyroscope drift over a long period. Anaccelerometer is an electromechanical device used to measureacceleration forces. Such forces may be static, like the continuousforce of gravity or, as is the case with many mobile devices, dynamic tosense movement or vibrations. A motion sensor, such as Bosch BNO055, canbe used for sensing. The sensor consists of accelerometer, gyroscope andmagnetometer, from which the data is fused into stable three-axisorientation output. The orientation references the direction of gravityand Earth's magnetic field. The sensor chip is small enough to beattached to battery cover. When used alone, the accelerometer can detectacceleration and the gyroscope can detect angular velocity. In oneembodiment, the accelerometer includes a high cross axis sensitivity,where the accelerometer detects disturbances of delta X˜0.002, deltaY˜0.001, and delta Z˜0.000.

The connector thermistor proximity 170 is a sensor able to detect thepresence of the container element without any physical contact. In oneembodiment, the proximity sensor emits an electromagnetic field or abeam of electromagnetic radiation (infrared, for instance), and looksfor changes in the field or return signal. The container element beingsensed is the proximity sensor's target. Different proximity sensortargets demand different sensors. For example, a capacitive proximitysensor or photoelectric sensor might be suitable for a plastic target;an inductive proximity sensor always requires a metal target. Proximitysensors can have a high reliability and long functional life because ofthe absence of mechanical parts and lack of physical contact between thesensor and the sensed object. Proximity sensors may also be used tomeasure the variation in distance between the cap device and thecontainer element. A sensor alarm may issue if the proximity sensordetects the container element being separated from the cap device for aperiod of time. The period of time may be between about 1 minute andabout 100 minutes. This sensor alarm ensures the container element isnot separated from the cap device for too long as to lose medication orexpose medication to air or degradation elements. The proximity sensoris a capacitive sensor. In other embodiments, touchless sensors may beused as the proximity sensor such as an inductive sensor(electromagnetic field) or an optical sensor, infrared, and the like. Inone embodiment, the proximity sensor is a conventional switch.

The force sensor unit 180 may be a piezoelectric sensor, a force-sensingresistor, a shear-beam load cell, or a force-sensing capacitor. Apiezoelectric sensor is a device that uses the piezoelectric effect, tomeasure changes in pressure, acceleration, temperature, strain, or forceby converting them to an electrical charge. The piezoelectric usingeffect of piezo resistive bridge circuit formed on silicon diaphragm,where the piezo resistance is changed according to strain by applyingforce to the diaphragm. A force-sensing resistor includes a materialwhose resistance changes when a force, pressure or mechanical stress isapplied. Force-sensing resistors consist of a conductive polymer, whichchanges resistance in a predictable manner following application offorce to its surface. They are normally supplied as a polymer sheet orink that can be applied by screen printing. The sensing film consists ofboth electrically conducting and non-conducting particles suspended inmatrix. The particles are sub-micrometer sizes, and are formulated toreduce the temperature dependence, improve mechanical properties andincrease surface durability. Applying a force to the surface of thesensing film causes particles to touch the conducting electrodes,changing the resistance of the film. As with resistive based sensors,force-sensing resistors require a relatively simple interface and canoperate satisfactorily in moderately hostile environments. Compared toother force sensors, the advantages of FSRs are their size (thicknesstypically less than 0.5 mm), low cost and good shock resistance.Force-sensing capacitors include a material whose capacitance changeswhen a force, pressure or mechanical stress is applied. Force sensitivecapacitors are examples of parallel plate capacitors. For smalldeflections, there is a linear relationship between applied force andchange in capacitance. A shear beam load cell uses regular strain gages,which are resistors that change the resistance with deformation.

In one embodiment, the temperature sensor includes an error readinggreater than or equal to about 0.023 degrees Celsius, and an accuracyless than or equal to about 97.6%. Generally speaking, the temperaturesensor may be selected from the group consisting of: NegativeTemperature Coefficient (NTC) thermistor, Resistance TemperatureDetector (RTD), Thermocouples, and Semiconductor-based sensors. Thetemperature sensor may also include a temperature alarm, that sounds offwhen a specified temperature is reached. The specified temperature maybe set by the medication and its requirements for storage. In oneembodiment, the specified temperature is set between about 20° C. andabout 30° C. to ensure the medication is properly stored.

A Negative Temperature Coefficient (NTC) thermistor is a thermallysensitive resistor that exhibits a large, predictable, and precisechange in resistance correlated to variations in temperature. An NTCthermistor provides a very high resistance at low temperatures. Astemperature increases, the resistance drops quickly. Because an NTCthermistor experiences such a large change in resistance per ° C., smallchanges in temperature are reflected very fast and with high accuracy(0.05 to 1.5° C.). Because of its exponential nature, the output of anNTC thermistor requires linearization. The effective operating range isabout −50 to about 250° C. for gas encapsulated thermistors or about150° C. for measurements.

A Resistance Temperature Detector (RTD) is also known as a resistancethermometer, measures temperature by correlating the resistance of theRTD element with temperature. An RTD consists of a film or, for greateraccuracy, a wire wrapped around a ceramic or glass core. The mostaccurate RTDs are made using platinum but lower cost RTDs can be madefrom nickel or copper. However, nickel and copper are not as stable orrepeatable. Platinum RTDs offer a fairly linear output that is highlyaccurate (0.1 to 1° C.) across −200 to 600° C. While providing thegreatest accuracy, RTDs also tend to be the most expensive oftemperature sensors.

Thermocouple is a temperature sensor type that consists of two wires ofdifferent metals connected at two points. The varying voltage betweenthese two points reflects proportional changes in temperature.Thermocouples are non-linear, requiring conversion when used fortemperature control and compensation, typically accomplished using alookup table. Accuracy is low, from about 0.5 to about 5° C. However,they operate across the widest temperature range, from about −200 toabout 1750° C.

Semiconductor-based sensors are placed on integrated circuits (ICs).These sensors are effectively two identical diodes withtemperature-sensitive voltage vs current characteristics that can beused to monitor changes in temperature. They offer a linear response buthave the lowest accuracy of the basic sensor types at about 1 to about5° C. They also have the slowest responsiveness (about 5 to about 60 s)across the narrowest temperature range (−70 to 150° C.).

The wireless module is for wireless communication capabilities forcommunicating with a computer or mobile device. For example, thewireless module may be Bluetooth®-enabled, Wi-Fi-enabled, Infrared,and/or any other wireless communication interface-enabled forcommunicating wirelessly with other local devices. Examples of wirelesscommunication interfaces may include, but are not limited to, anIntranet connection, Internet, ISM, Bluetooth® technology, Wi-Fi,Wi-Max, IEEE 402.11 technology, radio frequency (RF), Infrared DataAssociation (IrDA) compatible protocols, Local Area Networks (LAN), WideArea Networks (WAN), Shared Wireless Access Protocol (SWAP), anycombinations thereof, and other types of wireless networking protocols.

As shown in FIG. 3A, the main housing 130 includes a housing lumen 131disposed within a stepped portion 132 including a first housing member133, a second housing member 134, and a plurality of openings 135disposed between the first housing member 133 and the second housingmember 134. The second housing member 134 includes a plurality of tabopenings 136 disposed on the bottom portion of the second housing member134. In one embodiment, the plurality of tab openings 136 include agenerally L-shape to permit locking of the main housing with the sensorsocket 150. The first housing member 133 includes a first diameter D1and the second housing member 134 includes a second diameter D2, asshown in FIGS. 3B-3C. The first diameter D1 operably couples with thetube connector 140. The first housing member 133 includes an innerannular ring 137, as shown in FIGS. 3C-3D. The second diameter D2operably couples with the a sensor cover 160, a connector thermistorproximity 170, a battery cover, a force sensor unit 180, a memorycircuit 190, an accelerometer 200, a temperature sensor 210, a battery220, a PCB cap 230, and a battery cover 240. The inner annular ring 137includes a bottom lipped portion 138, as shown in FIGS. 3C-3D.

As shown in FIGS. 4A-4D, the tube connector 140 includes a topconnecting portion 141 and a bottom portion 142 with a central tubelumen 143 disposed through the top connecting portion 141 and the bottomportion 142. The central tube lumen 143 includes a hollow central tip144 and a threaded interior portion 145. As shown in FIG. 4B, the hollowcentral tip 144 includes a hollow opening 146, and the top connectingportion 141 includes an annular ring 147 disposed around the centraltube lumen 143. The hollow central tip 144 operably couples with thetemperature sensor 210 and the connector thermistor proximity 170. Thethreaded interior portion 145 includes a diameter D3 and the annularring 147 includes a diameter D4, as shown in FIG. 4D. The threadedinterior portion 145 operably couples with the top connecting portion ofthe container 110 as to secure the cap device to the container 110. Thediameter D3 is sized to fit the top portion of the container 110. Thediameter D4 is sized to fit sensor socket 150 and the annular ring 147operably couples with sensor socket 150. The central tube lumen 143includes a bottom portion 148 that operably couples with the sensorcover 160. The bottom portion 142 includes a lip 149 that abuts bottomlipped portion 138 of the inner annular ring 137.

As shown in FIGS. 5A-5D, the sensor socket 150 includes a top socketportion 151 and a bottom socket portion 152. The top socket portion 151includes an annular lumen 153 and the bottom socket portion 152 includesa plurality of outer tabs 154 on the top surface of the bottom socketportion 152. The annular lumen 153 includes a diameter D5, as shown inFIG. 5C, which operably couples with the diameter D4 of the annular ring147 of the tube connector 140. The bottom socket portion 152 includes aplurality of lower tabs 157 on the bottom surface of the bottom socketportion 152. The plurality of outer tabs 154 operably couple with theplurality of openings 135 of the main housing 130 as to secure thesensor socket 150 within the main housing 130. As shown in FIG. 5C, theplurality of outer tabs 154 are separated by distance D6 which operablycouples with the diameter D2 of the main housing 130. The annular lumen153 includes a bottom seated portion 155 with a bottom opening 156, asshown in FIG. 5D. The bottom seated portion 155 includes a plurality ofsides 158 forming a seat 159 that holds the force sensor unit 180 to sitat the bottom of the annular lumen 153 and abut the sensor cover 160 ontop of the force sensor unit 180, as shown in FIG. 6A. In oneembodiment, the plurality of sides 158 are generally in an X-formation,although other formations may be used such as a Y formation in otherembodiments. The bottom opening 156 is sized to permit the force sensorunit 180 and the connector thermistor proximity 170 to operably couplewith the PCB cap 230 and electronics, as shown in FIG. 6A. In oneembodiment, the plurality of lower tabs 157 include a generally L-shapeas to secure the PCB cap 230, although other shapes may be used.

As shown in FIG. 7A-7C, the sensor cover 160 includes a top sensor cover161 and a bottom sensor cover 162. The bottom sensor cover 162 includesa plurality of holders 163 and the top sensor cover 161 includes asensor opening 164 traversing the top and bottom sensor covers. Theplurality of holders 163 include a first side 165 and a second side 166sized to receive the plurality of sides 158 of the bottom seated portion155. The plurality of sides 158 are generally in opposed and align withthe X shape formation of the plurality of sides 158 of the sensor socket150. The sensor cover 160 includes a diameter D8 which aligns with thediameter D5 of the sensor socket 150 and the annular lumen 153. Thesensor opening 164 is sized to permit the connector thermistor proximity170 and operably couple the force sensor unit 180, as shown in FIGS.8A-8D.

As shown in FIGS. 8A-8C, the sensor cover 160 operably couples theconnector thermistor proximity 170 and the force sensor unit 180. Theforce sensor unit 180 is disposed on the bottom sensor cover 162 and thesensor opening 164, as shown in FIG. 8D. The connector thermistorproximity 170 connects to the temperature sensor 210 and the forcesensor unit 180. In one embodiment, the connector thermistor proximity170 operably couples with end terminal regions 172.

As shown in FIGS. 9A-9C, the PCB cap 230 is shown including theconnector thermistor proximity 170 disposed on the PCB cap, the forcesensor unit 180 operably coupled with the connector thermistor proximity170, the temperature sensor 210 operably coupled with the connectorthermistor proximity 170, the memory circuit 190 disposed on the PCB cap230, and the accelerometer 200 disposed through the PCB cap 230.

As shown in FIG. 10A-10C, the accelerometers 200 are operably coupledwith the battery cover 240 and are situated below the PCB cap 230.

As shown in FIGS. 11A-11B, the battery 220 is disposed within thebattery cover 240. The battery cover 240 includes a central holdingportion 242 disposed in the center and an outer annular ring 243. Theouter annular ring 243 includes a plurality of tabs 244. The pluralityof tabs 244 are separated by a diameter D8, which aligns with diameterD2 of the main housing and couple with the plurality tab openings 136.The central holding portion 242 includes a diameter D9 to operablycouple with the battery 220.

As shown in FIGS. 12A-12B, the battery 220 includes a diameter D10 whichaligns with the diameter D9 of the batter cover 240.

As shown in FIG. 13, the PCB cap 230 includes circuitry 231 for inputand control of the temperature sensor 210, the force sensor unit 180,the connector thermistor proximity 170, the accelerometer 200, and thememory circuit 190.

As shown in FIG. 14, the procedure for acquisition 202 starts withchecking the cap device state 204. If the state of the cap device haschanged in step 206, then the cap device determines if it's on or offthe container element 208. If the cap device is off, then the cap devicecreates a dataset with a timestamp, a state of the cap device, theorientation of the cap device, and a temperature of the cap device instep 207. If the cap device is on, then the cap device checks theorientation in step 250. After step 250, the cap device in step 260 tocheck the orientation of the cap device and determines if the cap deviceis upright along the axial direction. If the cap device is not upright,the procedure reverts back to step 250 to check the orientation of thecap device and notifies the user to correct the orientation in step 262.If the cap device is not upright after checking the orientation at least5 times, then step 207 creates a dataset with a timestamp, a state ofthe cap device, the orientation of the cap device, and a temperature ofthe cap device. If the cap device is upright, the step 270 measures theforce of the container element. Then step 280 creates a dataset with atimestamp, a state of the cap device, the orientation of the cap device,and a temperature of the cap device. Both step 207 and step 280 proceedback to step 204 to check the cap device state.

An alternative embodiment of the medication adherence apparatus 300 isshown in FIG. 15A. The medication adherence apparatus 300 comprises acontainer element 310 and a first cap device 320 and a second cap device330, as shown in FIG. 15A. The container element 310 may be anycontainer element to house a medication, such as an ointment tube,wide-mouthed plastic jar, or a platform developed for storage, display,and utilization of medicament container such as a tube, pill bottle,balm jar or tray. The medication may be any type of medication, eitherin pill, powder, liquid, or gas form. The cap state comprises the forceor weight of the container element, the orientation of the first capdevice 320 or second cap device 330, the temperature of the first capdevice 320 or second cap device 330, and the time stamp including theday, time, and date. The force or weight of the container element 310 isobtained when the container element 310 is inserted into the first capdevice 320 or the second cap device 330. The temperature inside themouth of the container element 310 is obtained by the first cap device320 or second cap device 330. The presence or absence of the containerelement 310 in the first cap device 320 is detected by the first capdevice 320. The orientation of the first cap device 320 or second capdevice 330 is detected to determine if the first cap device 320 orsecond cap device 330 and/or the container element 110 is upright, whichis generally along the vertical axis 301. And any movements of the firstcap device 320 or second cap device 330 may be detected, such as alongthe vertical axis 301, the longitudinal axis 303, or the lateral axis305. The second cap device 330 detects the weight of the containerelement 310. The first cap device 320 or second cap device 330 receivesa medication schedule and notification parameters to notify a patient byan alarm if medication is missed. The alarm may be an audio sound, avisual notification, an electronic notification, or a cell phonenotification.

As shown in FIG. 15B, the medication adherence apparatus 300 and thecomponents of the first cap device 320 and the second cap device 330.The first cap device 320 includes a first main housing 340, a firstbattery cover 350, a first PCB cap 360, a first battery 370, and adetector switch 380. The second cap device 330 includes a bottomconnector 390, a second battery 470, a bottom sensor socket 400, asecond battery cover 410, a second PCB cap 420, a force sensor 430, anaccelerometer 440, a wireless module 450, and a memory circuit card 460.

As shown in FIG. 15C, the first battery cover 350 is operably disposedover the first main housing 340 and the first battery 370 to enclose thetop portion of the first cap device 320. The first main housing 340secures the first cap device 320 to the container element 310 by way ofa threaded connection or capped connection 312 on the top end of thecontainer element 310. The first battery 370 is operably disposed overthe first PCB cap 360 and the detector switch 380 is operably coupledwith the PCB cap 360 as to detect the movement and connection of thefirst cap device 320 to the container element 310. The detection signalis sent to remote module to notify the user if the first cap device 320is secured to the container element 310 and notifies a program or moduleevery time the first cap device 320 is removed or secured to thecontainer element 310. The first battery cover 350 may include a snapfit connection to secure to the first main housing 340, as shown in FIG.15D.

As shown in FIG. 15C, the bottom end 314 of the container element 310 isoperably secured on the bottom connector 390. The bottom connector 390may be altered such that different types of container elements 310 maybe secured with the second cap device 330. The force sensor 430 isoperably disposed under the top portion of the bottom connector 390 asto detect the force or weight of the container element 310 secured intothe second cap device 330.

The force sensor 430 is operably disposed on the bottom sensor socket400 and operably coupled to the second PCB cap 420. The bottom sensorsocket 400 includes a rigid snap connection to the second battery cover410. The second PCB cap 420 is operably disposed within the bottomsensor socket 400 and on top of the second battery cover 410. The secondPCB cap 420 includes the wireless module 450, the force sensor 430, theaccelerometer 440, and the memory circuit 460, as shown in FIG. 15E. Theaccelerometer 440 is operably disposed in the second battery cover 410and through the second PCB cap 420. The accelerometer 440 detects theorientation of the second cap device 330 and registers when the secondcap device 330 is upright along vertical axis direction 301 so theweight can be measured. The accelerometer 440 also detects movements ofthe container element 310 such as twisting cap device open or close,shaking the container element 310, or tilting of the container element310. The second battery 470 is operably disposed within the secondbattery cover 410, as shown in FIG. 15F. Optionally, an LED light 480 isdisposed within the second battery cover 410 as to indicate a status oralarm.

The LED light 480 comprise 2 ultra-bright LED chips with a viewing angleof about 120°, forming various color combinations (blue/green, blue/red,red/green, yellow/green) and producing unique color blends. The LEDlight 480 can achieve variable hues and intensity levels tailoring to achosen ambience. The LED light 480 includes a low power consumption, IRreflow solderable, and automation friendly series operates under acurrent as low as 1 mA and meet industrial temperature ratings of −40 Cto +85 C.

The detector switch 380 is a type of switch has to be touched by anobject to operate and send a signal. In one embodiment, the detectorswitch is a tactile sensor that measures information arising from firstcap device being turned on the top of the container element anddisconnecting or connecting with the container element. Tactile sensorsare capable of detecting stimuli resulting from mechanical stimulation,temperature. Tactile sensors may be of different types includingpiezoresistive, piezoelectric, capacitive and elastoresistive sensor.Piezo touch switches are based on mechanical bending of piezo ceramic,typically constructed directly behind a surface. A resistance switchneeds two electrodes to be physically in contact with somethingelectrically conductive to operate. A capacitance switch needs oneelectrode to function. The electrode can be placed behind anon-conductive panel.

Optionally, a temperature sensor may be operably disposed within thebottom connector 390 or the tube connector 590. The temperature sensordetects the temperature inside the mouth of the container element 310.Optionally, a connector thermistor proximity may be operably coupled thebottom sensor socket 400 and the PCB cap 230. The connector thermistorproximity sensor senses when the container element 310 is present orabsent from the second cap device 330.

An alternative embodiment of the medication adherence apparatus 500 isshown in FIG. 16A. The medication adherence apparatus 500 comprises acontainer element 510 and a first cap device 520 and a second cap device530, as shown in FIG. 16A. The container element 510 may be anycontainer element to house a medication, such as an ointment tube,wide-mouthed plastic jar, or a platform developed for storage, display,and utilization of medicament container such as a tube, pill bottle,balm jar or tray. The medication may be any type of medication, eitherin pill, powder, liquid, or gas form. The cap state comprises the forceor weight of the container element, the orientation of the first capdevice 520 or second cap device 530, the temperature of the first capdevice 520 or second cap device 530, and the time stamp including theday, time, and date. The force or weight of the container element 510 isobtained when the container element 510 is inserted into the first capdevice 520 or the second cap device 530. The temperature inside themouth of the container element 310 is obtained by the first cap device520 or second cap device 530. The presence or absence of the containerelement 510 in the first cap device 520 is detected by the first capdevice 520. The orientation of the first cap device 520 or second capdevice 330 is detected to determine if the first cap device 520 orsecond cap device 530 and/or the container element 510 is upright, whichis generally along the vertical axis 301. And any movements of the firstcap device 520 or second cap device 530 may be detected, such as alongthe vertical axis direction 501, the longitudinal axis 503, or thelateral axis 505. The second cap device 530 detects the weight of thecontainer element 510. The first cap device 520 or second cap device 530receives a medication schedule and notification parameters to notify apatient by an alarm if medication is missed. The alarm may be an audiosound, a visual notification, an electronic notification, or a cellphone notification.

As shown in FIG. 16B, the medication adherence apparatus 500 and thecomponents of the first cap device 520 and the second cap device 530 areshown. The first cap device 520 includes a first main housing 540, afirst battery cover 550, a first PCB cap 560, a first battery 570, and adetector switch 580. The second cap device 530 includes a bottomconnector 590, a second battery 670, a bottom sensor socket 600, asecond battery cover 610, a second PCB cap 620, a force sensor 630, anaccelerometer 640, a wireless module 650, and a memory card 660.

As shown in FIG. 16C, the first battery cover 550 is operably disposedover the first main housing 540 and the first battery 570 to enclose thetop portion of the first cap device 520. The first main housing 540secures the first cap device 520 to the container element 510 by way ofa threaded connection or capped connection 512 on the top end of thecontainer element 510. The first battery 570 is operably disposed overthe first PCB cap 560 and the detector switch 580 is operably coupledwith the PCB cap 560 as to detect the movement and connection of thefirst cap device 520 to the container element 510. The detection signalis sent to remote module to notify the user if the first cap device 520is secured to the container element 510 and notifies a program or moduleevery time the first cap device 520 is removed or secured to thecontainer element 510. The first battery cover 550 may include a snapfit connection to secure to the first main housing 540, as shown in FIG.16D.

As shown in FIG. 16C, the bottom end 514 of the container element 510 isoperably secured on the bottom connector 590. The bottom connector 590may be altered such that different types of container elements 510 maybe secured with the second cap device 530. The force sensor 630 isoperably disposed under the top portion of the bottom connector 590 asto detect the force or weight of the container element 510 secured intothe second cap device 530.

The force sensor 630 is operably disposed on the bottom sensor socket400 and operably coupled to the second PCB cap 620. The bottom sensorsocket 600 includes a rigid snap connection to the second battery cover610. The second PCB cap 620 is operably disposed within the bottomsensor socket 600 and on top of the second battery cover 610. The secondPCB cap 620 includes the wireless module 650, the force sensor 630, theaccelerometer 640, and the memory circuit 660, as shown in FIG. 16E. Theaccelerometer 640 is operably disposed in the second battery cover 610and through the second PCB cap 620. The accelerometer 640 detects theorientation of the second cap device 530 and registers when the secondcap device 330 is upright along vertical direction 501 so the weight canbe measured. The accelerometer 640 also detects movements of thecontainer element 510 such as twisting cap device open or close, shakingthe container element 510, or tilting of the container element 510. Thesecond battery 670 is operably disposed within the second battery cover610, as shown in FIG. 16F. Optionally, an LED light 680 is disposedwithin the second battery cover 610 as to indicate a status or alarm.

Optionally, a temperature sensor may be operably disposed within thebottom connector 590 or the tube connector. The temperature sensordetects the temperature inside the mouth of the container element 510.Optionally, a connector thermistor proximity may be operably coupled thebottom sensor socket 600 and the PCB cap 620. The connector thermistorproximity sensor senses when the container element 510 is present orabsent from the second cap device 530.

Adherence Monitoring: Cap Device and Data Acquisition, Storing andSharing

In one embodiment, data recording comprises recording data in intervalsof about 1 second in sets consisting of: a Timestamp (Unix-time); a Capdevice status (On/Off); an Orientation of Device (16 bit code ofmotion-sensor, Z-gravity vector), a Force (for calculating weight), aTemperature (Resistance of thermistor). In one embodiment, a triggerevent time-based may be a time period for continuous tracking oftemperature and other tracking parameters. In one embodiment, the timeperiod may be about 30 minutes.

Data storing comprises storing data in a floating buffer of about 50 toabout 200 datasets. When a new set of Data is created, old data is movedto next “slot” and latest set stored in first slot. In one embodiment,the newest set of Data is always in first slot. Data is not deleted fromdevice after reading by a mobile device. But when the Buffer is full,then the oldest set is deleted whenever a new set is added in subsequentorder.

In one embodiment, data sharing comprises broadcasting 1 Service with a1 Characteristic for each Value, a +1 Characteristic for slot-selection.Then the mobile device connects to cap device, selects Dataset, readsdesired Values, and selects next Dataset. In one embodiment, the datasharing comprises broadcasting 1 Service with a 1 Characteristic forlive-timestamp in the cap device, a +1 Characteristic for settingTimestamp through the mobile device, a +1 Characteristic to initiatepairing mode. In one embodiment, the data sharing comprises broadcasting1 Service with a 1 Characteristic for Battery Level of the Cap Device.In one embodiment, the data sharing comprises broadcasting 1 Servicewith Characteristics for uploading medication schedule to Device foruser-notifications.

Security/Pairing/Bonding comprises using Bluetooth Low Energy (BLE)Encrypted Connection through Trusted device database. In one embodiment,any device is allowed to pair/bond. The cap device may receive updatesand further security measures at a later time point. In one embodiment,at first startup of the device, the next mobile device connecting isallowed to bond, and hence is able to access the datasets and settings;other attempts are rejected, unless: bonded device activates paringmode, then bonding of another device are allowed for about 30 seconds.

An alternative embodiment of the medication adherence apparatus 700 isshown in FIG. 17A. The medication adherence apparatus 700 comprises acontainer element 710 and a third cap device 720, as shown in FIG. 17A.The elements, sensors, and components of the third cap device areinterchangeable with the first cap device and second cap device. Thecontainer element 710 may be any container element to house amedication, such as an ointment tube, wide-mouthed plastic jar, or aplatform developed for storage, display, and utilization of medicamentcontainer such as a tube, pill bottle, balm jar or tray. The medicationmay be any type of medication, either in pill, powder, liquid, or gasform. The cap state comprises the force or weight of the containerelement, the orientation of the third cap device 720, the temperature ofthe third cap device 720, and the time stamp including the day, time,and date. The force or weight of the container element 710 is obtainedwhen the container element 710 is inserted into the third cap device720. The temperature inside the mouth of the container element 710 isobtained by the third cap device 720. The presence or absence of thecontainer element 710 in the third cap device 720 is detected by thethird cap device 720. The orientation of the third cap device 720 isdetected to determine if the third cap device 720 or and/or thecontainer element 110 is upright, which is generally along the verticalaxis 701. And any movements of the third cap device 720 may be detected,such as along the vertical axis 701, the longitudinal axis 703, or thelateral axis 705. The third cap device 720 receives a medicationschedule and notification parameters to notify a patient by an alarm ifmedication is missed. The alarm may be an audio sound, a visualnotification, an electronic notification, or a cell phone notification.

As shown in FIG. 17A-17B, the medication adherence apparatus 700 and thecomponents of the third cap device 720 are shown in one embodiment. Thethird cap device 720 includes a PCB 730, a first main housing 740, afirst battery cover 750, a first spacer cap 760, a battery 770, a loadcell 780, a bottom stop cap 790, a light pipe 800, and a base cap 810, aSurface Mount Transducer 820; and a plurality of screws 830. The loadcell 780 detects the movement and connection of the third cap device 720to the container element 710. The detection signal is sent to a remotemodule to notify the user if the third cap device 720 is secured to thecontainer element 710 and notifies a program or module every time thethird cap device 720 is removed or secured to the container element 710.The first main housing 740 includes a top threaded portion 741 to securethe container element 710 to the top portion of the first main housing740. As shown in FIG. 17E, a proximity sensor 916 is disposed on the topportion of the first main housing 740 to detect the securement of thecontainer of the first main housing. In one embodiment, the proximitysensor is a copper wire operable to detect the presence of the firstcontainer by way of electrical connection. In another embodiment, theproximity sensor 916 is a copper sheet 917 disposed on the top portionof the first main housing 740. The copper sheet 917 is operably coupledto a shield 919 to protect the proximity sensor 916 from false readingswhen connected with the container. The proximity sensor 916 can connectwith the PCB by way of a coupler 921.

As shown in FIG. 17C, the battery 770 is operably disposed in the firstbattery cover 750 is operably disposed over the PCB 730. The firstbattery cover 750 is operably coupled with the first spacer cap 760. Thefirst spacer cap 760 is operably coupled with the light pipe 800 and isoperably disposed over the PCB 730. A first screw 832 and a second screw834 secures the first main housing 740 to the first spacer cap 760. ThePCB 730 is operably coupled with the Surface Mount Transducer 820 andthe PCB 730 is operably disposed with the load cell 780. The load cell780 is operably disposed on the base cap 810.

In another embodiment, as shown in FIG. 17D, the load cell 780 isoperably coupled to top portion of the first main housing 740. Thebottom stop cap 790 is disposed on the top portion of the first mainhousing 740 with the load cell 780 and secured with the plurality ofscrews 830. The battery 770 and the first battery cover 750 are operablydisposed on the bottom portion of the first main housing 740 with thefirst spacer cap 760 and the base cap 810. The light pipe 800, PCB 730,and the Surface Mount Transducer 820 are operably disposed in the middleportion of the first main housing.

In another embodiment, as shown in FIG. 17F, the PCB 730, the firstbattery cover 750, the first spacer cap 760, the battery 770, the bottomstop cap 790, the light pipe 800, the Surface Mount Transducer 820 aremounted around the load cell 780.

As shown in FIG. 18A-18B, the first main housing 740 includes a firstscrew hole 742 and second screw hole 744 to operably secure the firstmain housing 740 to the first spacer cap 760 by way of the first screw832 and the second screw 834. The first main housing 740 includes acentral lumen 748 that encloses the PCB 730, the first battery cover750, the first spacer cap 760, the battery 770, the load cell 780, thebottom stop cap 790, the light pipe 800, a base cap 810, the SurfaceMount Transducer 820. The first main housing 740 secures to thecontainer by way of a threaded connection or capped connection 712 onthe top end of the container element. The first main housing 740includes a light hole 746 through which the light pipe 800 traverses forthe alarm notification.

As shown in FIG. 19A-19B, the first battery cover 750 including a topside 751 and a bottom side 753 in a general circular profile. The topside 751 includes a central holding lumen 752 to house the battery, andthe bottom side 753 includes a plurality of tabs 754 to secure the firstbattery cover 750 to the PCB and operably couple with the PCB. The topside 751 includes a holding tab 756 to secure the battery within thecentral holding lumen 752 and a central bore 757 traversing the top side751 and the bottom side 753. The bottom side 753 includes a plurality ofbattery contacts 758 to transmit the battery's electrical energy to thePCB and bottom tab. In one embodiment, the top side 751 includes a topopen portion 759 to permit installation of the battery. Alternatively, aside insertion opening could be employed.

As shown in FIGS. 20A-20B, the first spacer cap 760 includes a top side761 and a bottom side 763 in a general curvilinear profile. The top side761 includes at least two screw lumens 762 including an inner threadedsurface to engage the first screw and the second screw. The top side 761includes a light pipe lumen 764 to permit the light pipe to traverse thebottom side 763 and the top side 761 and protrude through the light pipelumen 764. The bottom side 763 includes at least two threaded lumens 766to engage a plurality of screws and secure the PCB to the bottom side ofthe 763 of the first spacer cap 760. The bottom side 763 includes atleast two second threaded lumens 768 to secure the load cell and thebottom stop cap to the first spacer cap 760. The bottom side 763includes a light pipe holder 767 to secure the bottom end of the lightpipe. The side of the first spacer cap 760 may include a c-shape 769 foroperably coupling with the first main housing 740

As shown in FIGS. 21A-21B, the light pipe 800 includes a central lightportion 802 extending from a bottom base portion 804. The central lightportion 802 is a light emitting alarm for the third cap device 720. Inone embodiment, the central light portion 802 may be light emittingdiode, although other light emitting energies may be used, such asfluorescence, incandescent light bulb, High-intensity discharge lamps,and the like. The central light portion 802 includes a top slantedportion 803, which operably couples with the first main housing 740. Thebottom base portion 804 includes a bottom side 805 in which twoelectrical contacts 806 are disposed. The bottom side 805 sits on top ofthe PCB and the two electrical contacts 806 operably couple with the PCBto operate and control the light pipe 800.

As shown in FIGS. 22A-22B, the PCB 730 includes a top side 731 and abottom side 733 in a general circular configuration. The PCB 730includes at least two screw holes 732 located on opposing sides andtraversing the top side 731 and the bottom side 733. The at least twoscrew holes 732 permit the plurality of screws 830 to secure the PCB tothe first spacer cap 760. The PCB 730 includes at least two electricalcontacts 734 to secure the light pipe 800 and operably couple with theelectrical contacts 806 of the light pipe 800. The PCB 730 includes atleast two battery contacts 738 to operably couple with the first batterycover 750 and the plurality of tabs 754. The PCB 730 includes a circularpass through 737 through which the at least two second threaded lumens768 of the first spacer cap 760 pass through to secure the load cell.The Surface Mount Transducer 820 is operably disposed on the bottom side733. The surface mount transducer 820 sounds an audible alarm whensignaled by the PCB and the load cell.

As shown in FIGS. 22C-22E, the PCB layout 900 on the top side 731 of thePCB 730 and on the bottom side 733. The top side 731 includes an Analogto Digital Converters integrated circuit 910, an accelerometer 912, amemory card 914, a Proximity sensor 916, a LED array 918, a firstconnector 920, a JTAG connector 974. The bottom side 733 includes aBluetooth module 940, a speaker 942, a switch 944, a temperature sensor946, a plurality of connectors 948, a DC/DC converter 950, a load switch952, a supervisory circuit 954, a clock crystal 956, first set ofcapacitors 958, thick film resistors 960, a second capacitor 962, and abridge connector 970 operably coupled with the load cell.

As shown in FIG. 22E, a schematic of the PCB layout 900 is showncomprising the bridge connector 970, which is operably coupled with theload cell for measuring the third cap device and the associatedcontainer. The bridge connector 970 is operably coupled with a diode973, which sends the load signal to the Analog to Digital Convertersintegrated circuit 910. At first Startup, the third cap Device is a2-Point calibrated for weight-measurement and also proximity. Amulti-point calibration and auto-tar (zeroing) functionality is in oneembodiment. The calibration data stored in non-volatile ram storagecomponent, so values are still stored after battery change. Thecalibration comprises using the proximity sensor to determine if the capdevice is on/off the container, rather than checking if the proximitysensor is operable. And after the accelerometer interrupt has occurred,the proximity sensor checks if the cap device is on or off thecontainer. If the proximity sensor detects that the cap device is on thecontainer, then a weight measurement is conducted with the load cell. Ifoff, the cap-off event is saved without taking the weight. Theaccelerometer is used to initiate the checking of the proximity sensor.

During Start-up, the hardware conducts an Initialization of BLE andSensors. The sensors are I2C-slaves, according to one embodiment. I2C isa serial protocol for two-wire interface to connect low-speed deviceslike microcontrollers, EEPROMs, A/D and D/A converters, I/O interfacesand other similar peripherals in embedded systems. I2C is a synchronous,multi-master, multi-slave, packet switched, single-ended, serialcomputer bus. Bluetooth module reads data from the sensors digitally.Sensors have each one or more “interrupt lines” connected to the BLEmodule to wake up the module (if asleep) and indicate new data has beencaptured. The Sensors include the accelerometer, the proximity sensor,the temperature sensor. The ADC is the Analog-Digital-Converter forreading the force-sensor. The Accelerometer detects generalmovement/activity of device and orientation during weight-measurement.The proximity sensor detects if a container is attached to the capdevice or not attached to the cap device. The proximity sensor consistsof chip on the PCB to read the sensor and the actual sensor/antenna. Thetemperature sensor captures Temperature of the Device/Medication. TheRTC is the Real Time Clock for time (alternatively the BLE module cancapture time). Power-Management: Boost-Converter to supply a stable andhigher than battery voltage to force sensor. Speaker and LED:notifications to user. Additional memory communicating through QSPI. TheIdle-mode comprises as many components asleep as possible, BLE can beconnected to (or not) and accelerometer watches for activity.Accelerometer-Interrupt comprises triggers BLE module which turns onproximity sensor.

When the Proximity sensor detects Cap Off of the container comprisessaving “Cap off event” to memory and going back to the Idle-mode. Whenthe Proximity sensor detects the third Cap device is on the container,it comprises waking up ADC to measure weight. The third cap device checkfor accelerometer for no movement and proper orientation. If the thirdcap device is not upright, then it warns patient through app andindicators and go back to check the accelerometer for no movement andproper orientation. The third cap device tries 3 times and if the thirdcap device is not upright, it saves “Cap on event” with invalid weightto memory, “bad chime” and goes back to the Idle-mode. If the third capdevice is upright and still with no movement, then the third cap deviceinitiates weight-measurement. The ADC takes weight measurements (100samples) while watching accelerometer and proximity. If the weightmeasurement process is disrupted by movements or cap off, then the thirdcap device warns the user with a “bad chime” and tries again. If atleast three weight measurements are attempted and the weight measurementprocess is still disrupted, then it saves “Cap on event” with invalidweight to memory, “bad chime” and goes back to Idle-mode warning theuser. If a plurality of weight measurements are taken successfullywithout disruption, then it save “Cap on event” with valid weight tomemory, sounds a “good chime” or positive indication and goes back tothe Idle-mode.

The third cap device includes a Reminder-Functionality operation where asoftware application sends times of adherences to cap. If medicationwasn't taken yet, the third cap device sounds “good chime” 30 minsbefore adherence and on time of scheduled adherence, and the third capdevice sounds a “bad chime” 30 mins after adherence.

Capturing of Data from the software comprises storing events in abuffer. Whenever an event is being added, other events move one slot up,when buffer is full, the oldest event gets deleted. Buffer-Data(Service) consists of one characteristic for Time (Unixtime), Capstate,Orientation, Weight, Temperature and buffer-select. The softwareapplication writes into buffer-select which slot it wants to access andthen the third cap device loads the data of this slot into thecharacteristics accordingly. Therefore, the software application alwaysstarts reading at slot 1 an increases until it reads a slot whosetimestamp it has already read.

As shown in FIG. 23, a flowchart of the PCB layout 900 is showncomprising the load cell 780 operably coupled with the bridge connector970. The bridge connector 970 is operably coupled with the Analog toDigital Converters integrated circuit 910. The Analog to DigitalConverters integrated circuit 910 is operably coupled with the proximitysensor 916, a Real-time clock (RTC) 972, the accelerometer 912, and theBluetooth module 940. The Bluetooth module 940 is operably coupled withthe temperature sensor 946, the battery, the speaker 942, LED array 918,a JTAG connector 974, a USB port 976, and the memory card 914.

As shown in FIGS. 24A-24B, the bottom stop cap 790 includes a top side791 and a bottom side 793, and a general L-shape cross sectionalconfiguration. The bottom stop cap 790 includes at least two holes 792traversing the top side 791 and the bottom side 793. The at least twoholes 792 operably couple with the plurality of screws 830 to secure theload cell and bottom stop cap 790 to the at least two second threadedlumens 768 of the first spacer cap 760. The bottom side 793 forms aright angle with an L-shaped portion 794, such as to sit and dispose ontop of the load cell.

As shown in FIGS. 25A-25B, the load cell 780 includes a top side 781, abottom side 783, and a general rectangular configuration. The load cell780 may be a force sensor as previously indicated or a type oftransducer, specifically a force transducer. The load cell converts aforce such as tension, compression, pressure, or torque into anelectrical signal that can be measured and standardized. As the forceapplied to the load cell increases, the electrical signal changesproportionally. The load cell may be a hydraulic, pneumatic,piezoelectric, and strain gauge. Strain gauge load cells may be a Singlepoint shear beam, a Pancake, a Double-ended shear beam, a Canister loadcell, an S-type load cell, Wire rope clamps, a Tension link load cell. ATension link load cell measures tension force. Wire rope clamps are anassembly attached to a wire rope and measures its tension. An S-typeload cell comprises S-shaped spring element; can be used in bothcompression and tension. A Canister load cell comprises a cylindricalshaped spring element; can be used in both tension and compression. ADouble-ended shear beam comprises a spring element fixed at both endsand loaded in the center. A Pancake comprises low-profile load cellsoften used in vessel weighing; can be tension or compression. Singlepoint shear beam load cell comprises a spring element fixed at one endand loaded on the other.

As shown in FIGS. 25A-25B, the load cell 780 includes at least two holes782 traversing the top side 781 and the bottom side 783. The at leasttwo holes 782 operably couple with the plurality of screws 830 to securethe load cell and bottom stop cap 790 to the at least two secondthreaded lumens 768 of the first spacer cap 760. The at least two holes782 can include a seated portion, such that the screw head abuts theseated portion when the screws are fastened. The load cell 780 includesa bottom hole 784 on the bottom side 783 as to secure the load cell 780to the base cap 810 by way of a screw. The load cell 780 includes aplurality of electrical contacts 786 on the side of the load cell 780 tooperably couple with the PCB. The load cell 780 includes a load lumen788 through the load of the container may be measured. The load cell 780includes a bottom hole 789 on the bottom side 783, wherein the bottomhole 789 operably couples with the base cap to secure the load cell 780to the base cap 810. The Bluetooth module communicates with themedication adherence software application 1000, as further explainedbelow.

As shown in FIGS. 26A-26B, the base cap 810 includes a top side 811, abottom side 813, and a general circular configuration. The base cap 810includes a first hole 812 traversing the top side 811 and bottom side813, wherein the first hole 812 coaxially couples with the holes 782 ofthe load cell to secure the load cell to the base cap 810. In oneembodiment, the first hole 812 includes a seated portion, such that thescrew head abuts the seated portion when the screw is fastened. The basecap 810 includes a second hole 814 that coaxially couples with thebottom hole 789 of the load cell 780 to secure the load cell 780 to thebase cap 810. The base cap 810 includes a first stop 816 and a secondstop 817 which operably couple with the load cell 780 to seat the loadcell in the base cap 810. In one embodiment, the second stop 817 abutsthe L-shaped portion 794 of the bottom stop cap 790 and the first stop816 abuts the load cell. The base cap 810 includes a circular lip 818around the circumference of the top side 811. The base cap 810 includesa plurality of pads 819 on the bottom side 813.

As shown in FIG. 27, in one embodiment, the medication adherencesoftware application 1000 operates as follows: once the power is on1002. The medication adherence software application 1000 then runs acalibration step 1004. Once the calibration step 1004 is complete andconfirmed, samples for no weight is checked 1006, samples for a specificentered weight is checked 1008. Then, calculating the slope and offsetis in step 1010 and storing the slope and offset calculation in thememory card in step 1012. The slope and offset calculation is sent toactivate accelerometer interrupt in step 1014. Step 1016 waits for theinterrupt in step 1014 and receives an input from activating theaccelerometer interrupt is a disable ADC interrupt pathway 1040. Andafter the accelerometer interrupted has occurred, the proximity sensorchecks if the cap device is on or off the container in step 1017. If theproximity sensor detects that the cap device is on the container, then aweight measurement is conducted with the load cell proceeding todecision step 1018. If the cap device is off of the container, then acap-off event is saved without taking the weight measurement.

The disable interrupt proceeds to the decision step 1018 to start a newmeasurement. If a new measurement is started, then step 1020 records thetime and temperature. If a new measurement is not started, then step1022 waits for the sample. After the time and temperature are recordedin step 1020, the ADC interrupt is activated 1021 and step 1022 waitsfor the sample. Step 1022 receives two inputs and proceeds to step 1028to check the accelerometer measurement. If the accelerometer measurementis good, the step 1030 collects the accelerometer data. If theaccelerometer measurement is bad, the decision 1026 decides if there aretoo many bad readings. If there are not too many bad readings, thenmethod proceeds to step 1022 to wait for the sample. If there are toomany bad readings, then step 1024 waits X number of seconds to activatethe ADC interrupt. After waiting X number of seconds, the methodproceeds back to step 1022 to wait for the sample. If the accelerometermeasurement is good, then step 1030 collects the data and Decision 1032collects at least 100 samples. If 100 samples are not collected, thenthe method proceeds back to step 1022 to wait for the sample. If 100samples are collected, then the ADC is disabled, and step 1034 completesthe weight computation. The method proceeds to decision 1036 for the caponly. If there is a cap only, the ADC interrupt is disabled, and step1042 activates the accelerometer interrupt. After activating theaccelerometer interrupt in step 1042, the method proceeds back to step1016 to wait for interrupt. If there is not the cap only in decision1036, then step 1038 reports the measurement to the cloud or storagedevice.

In one embodiment, the load cell withstands about 200 g without changingthe zero point. The cap device tolerates higher forces (withstandingweight) that that of the ointment being weighed to reduce frequency ofproduct failure. If the ointment and container are greater than about200 g, then the change in zero point is increased for the withstandingweight. The cap device includes a proximity sensor on the PCB, accordingto one embodiment. The cap device detect if a tube/container is attachedto the third cap device. The cap device includes an ambient temperaturesensor capable of measuring about 0 to about 60° C. with accuracy of ±2°C. between about 0 and about 60° C. Out-of-specification temperatureswithin the third cap device can compromise the performance of the capdevice and storage of the prescription drug or ointment. Temperature isa parameter to be tracked by the device. The cap device includes aninclinometer. The third cap device measures tilt as it may affectaccuracy of the weight measurement. The third cap device includes anaccelerometer. The third cap device detects if the device is being movedor standing still. The load cell measures tubes up to about 100 g with aresolution between +/−0.1 g and +/−0.05 g. This parameter measures themass difference after each use. Maximum tube mass is about 100 g.Dispensed range is between about 1.5-about 4 gm based on number and sizeof lesions.

In one embodiment, the power management requirements pertain to how thethird cap device manages power. The third cap device measures batteryvoltage, such that there is a battery charge status. The third capdevice includes a low power mode to prevent discharge when the third capdevice is not in use by using low power requirements. The third capdevice minimizes internal battery discharge. The third cap deviceincludes a precision voltage regulation. Precision voltage achievesaccurate measurements. The third cap device includes a non-rechargeablebattery for enough power for the duration of use, according oneembodiment.

In one embodiment, the timing requirements comprise details about howthe third cap device creates and uses time. The third cap device log thetimes at which events occur. The third cap device requires an accuratetime stamp for data logging. The third cap device includes a real timeclock to determine when the patient takes their medication. The thirdcap device real time clock is accurate to +/− about 3 seconds afterabout 5 days of operation with Bluetooth connectivity. Time accuracy isfor defining time of adherences. Main PCB includes a coin cell tomaintain the real time clock and power the device. Battery power assiststo maintain time, in one embodiment, the Data requirements includecharacteristics of data handled by the third cap device. Data saved inthe third cap device is retrievable by Bluetooth. No wire connectionsare on the third cap device, in one embodiment. The third cap devicesaves at a minimum 80 events. If the device does not connect to a phone,the data is still available.

In one embodiment, the functional requirements include informationpertaining to the operation and behavior as they relate to the deviceusers. This third cap device functions in relationship to the user andother components. The third cap device measure tilt. Tilt may result inerroneous data measurements; tilt determines when measurements shouldand should not be taken. The third cap device report mass in a scalerfor grams. Data consistency simplifies verification of data flow fromthe device to the cloud. The third cap device report temperature in ascaler for degrees Celsius or Fahrenheit. The third cap device detectswhen an ointment tube is attached or detached. The connection anddisconnection of a tube/container to the third cap device providesvaluable adherence information. The third cap device includes a designconfiguration to minimize error introduced by inclination or detectinclination that leads to an erroneous measurement. Measurement accuracyis important for defining adherence.

In one embodiment, the mechanical performance requirements define howeach third cap device mechanically interacts with external devices andor accessories. The third cap device comprises multiple threadconfigurations to accommodate the most common tube threads. (threadsizes to include about 16, about 20, and about 28). The threads of thirdcap device include threads to match a commercially availablenon-prescription ointment.

In one embodiment, the external interface requirements define how thethird cap device communicates with external devices and or accessories.The third cap device includes BLE 5.0 for a wireless interface is usedfor third cap device communication to the Software App. The third capdevice includes a JTAG or serial port to load Software. A method ofentering firmware into the device and general testing is included in thecap device. The third cap device includes a base that is non-stick inone embodiment. If the base sticks to the counter, picking it up mayover stress the load. The third cap device material may be of plastic,metal, and the like. The third cap device is detectable and pairable toa phone. The third cap device connects via blue tooth or wirelesstechnology to a portable device.

The User Interface (UI) Requirements of the third cap device include thefollowing:

The third cap device emits yellow and green light as indicators. Greenis to respond to a positive event and yellow to respond to a negativeevent. The third cap device notifies the user through an audibleannunciator or speaker. The third cap device makes a plurality of soundsdepending on device states. The third cap device includes at least one(1) LED that can emit programmable light. The third cap device displaysone color at a time, in one embodiment; one light indicator is needed ata time. The audible annunciator creates two different tones, where onetone represents a positive event and one tone represents a negativeevent.

In one embodiment, the software and third cap device operate as follows:

If no interrupt for 24 hours, the cap device automatically takes ameasurement, initiated either by the third cap device itself or thesoftware app. Data is captured periodically and if no data is available,then an error report or message may be delivered by the third cap deviceor the software app. The cap device confirms medication use if othersensors are not working. Cap State can be defined as the on tube or offtube, Cap state on/off is an indicator for timing on when to take weightmeasurements. The proximity sensor detects if the container is on or ifthe container is off for the Cap state on or the Cap state off. The capdevice knows if the cap device is calibrate or un-calibrated. Thecalibration state determines if the weight measurements are accurate.The third cap device is programmable with a time for patient to takemedication a certain number of times a day. Medication taken at theprescribed time for efficacy. Reminders may be defined by presententries or by the user, reminders may be audible or visual cues under aparticular set of circumstances. The third cap device may send anaudible reminder or a visual reminder to connect to the software app.The third cap device reminds the patient to have the phone connected sodata can be sent to the cloud or other remote server. The time periodfrom last connect may be programmed into the third cap device. The thirdcap device comprises a number of event settings. In one embodiment, thenumber of events comprises 2 events/day for 5 weeks before re-settingthe number of events to zero from the software app. The third cap deviceincludes a sleep mode for components are put in sleep mode after areading is taken. The battery power and the components go into a lowpower consumption state. The ADC may be in lower power mode. The thirdcap device puts the components in the sleep mode if a good reading isnot obtained within 5 minutes of wake interrupt. The time period of 5minutes allow the users to apply medication and to conserve batterypower if good reading cannot be taken. The third cap device puts allcomponents in the sleep mode if inclinometer is more than about 5 counts(of 63) from vertical after 5 minutes. If the third cap device is laidsideways, then the third cap device goes into battery power conservationmode. The third cap device takes a force measurement if inclinometer isvertical within about 5 counts (of 63) from the vertical orientation.The third cap device takes a weight measurement that is reasonablyaccurate if the inclinometer is within about 5 degrees off the verticalorientation. The third cap device sends an audible alarm if the thirdcap device is not placed in the vertical orientation after 5 seconds ofthe third cap device being secured to the container. A good measurementis taken after medication is used and the third cap device remindpatient independent of app. The third cap device reports thenon-vertical orientation to app after 5 seconds of cap on. The softwareapp is notifying if the cap device is not vertical so the software appcan also remind the patient to place cap upright.

User interface requirements comprise the following:

Light indicator and audible alarm is initiated 30 minutes prior tomedication time if patient did not take medication. The cap deviceinitiates a reminder for patient to take medication determined if thecap device is on or off the container, a weight change detected in thecontainer, and within a time period window, such as 2 hours before. Thecap device includes a positive light indicator and a positive audiblealarm after successful weight measurement by the third cap device. Thecap device provides positive feedback to patient. The cap deviceincludes a negative light indicator and a negative audible alarm after atime period of about 30 minutes after medication time if no successfulweight measurement is obtained. The cap device sends a reminder forpatient to take medication through the software app. The cap deviceincludes a negative light indicator and a negative audible alarm after atime period of about 3 seconds when cap device is in on the containerand when the cap device is not placed in the vertical orientation. Thecap device sends a timely reminder for patient to place the capdevice/tube in the vertical orientation so a good accurate measurementcan be taken. The cap device includes multiple light indicators in theevent that is requested to be on, a yellow light indicator takesprecedence over green light indicator. Patient should not haveconflicting/overlapping indicators. The cap device includes a successfulmedication state and initiates a successful light indicator and asuccessful audible noise. The successful medication state isreinforcement to the patient and the negative medication state includesa negative noise. The software app activates the successful lightindicator and the negative audible noise independent of the cap deviceactivity or events. The software app can be used to test the cap devicefunctionality or independently notify the patient of an event. Thesoftware app activates all LED colors individually independent of Capactivity or events. Can be used to test the cap functionality orindependently notify the patient of an event. The successful audiblenoise is 2 tones alternating (E+C) 6 times of about 300 ms on and about300 ms off. The negative audible noise is different than the successfulaudible noise. A second successful audible noise is 1 tone (F) 3 timesof 300 ms on and 300 ms off. The second successful audible noise isdifferent than the negative audible noise. The cap device and softwarecan set up the successful audible noise and successful light indicators.The successful audible noise and successful light indicators arepositive feedback that programmed for the patient.

The cap device includes an acceleration measured at about 0.015 gresolution. Inclination determines if a measurement should be taken. Theaccelerometer is working both in read and interrupt mode. Theaccelerometer parameters for waking up the cap device.

In one embodiment, acceleration is sampled at about 10 Hz. This samplingis timed with the ADC sample rate which is about 10 Hz. Accelerometerprovides inclination of Z vector. Primary vector to determine if thetube/cap is upright and a good weight measurement can be taken.Accelerometer has +/−2 g={circumflex over ( )}+/−127 counts, thereforeresolution is about 0.015 g. Temperature is measured at about 0.1 Cresolution. Some medication is temperature sensitive and this isindicated on the medication storage temperature. Temperature sensor inaccelerometer working. Current accuracy is within 1° C. of dedicatedtemp sensor. Temp should be taken right at wake up as a surrogate formedication storage temperature. Load Cell/ADC able to measure force ingrams +/−0.05 g. Resolution is 0.005 g. Output should be in units to beused by the Software App. Load cell sample rate is 10 Hz. Lowest rate ofADC which sets this parameter. Load cell is filtered by averaging 100samples. Reduces noise by factor of 10; 10 seconds is reasonable for capto remain vertical; and not too much battery power is consumed. Batteryvoltage is read and sent to the app. App can indicate low batteryvoltage independent of cap indicators.

Pairing process can occur with any device. A process is pairs apatient's phone prior to first use. Measurement Data is reported fromapp requests. The type of units to be reported is in actual units usedin the phone app/cloud platform. A complete measurement can bemade—weight, time, temperature and cap state. Report is in grams,seconds (Unix Time), and degrees C. BT advertises every 5 seconds and isintermittent to save battery life, but not longer than 10 seconds suchthat it is difficult to connect app to cap device.

Software application comprises a 2 point calibration (0, 100 g), in oneembodiment. In order to achieve the accuracy, the load cells areindividually calibrated after insertion of a battery. Requires Interfacedocument to be updated and support added by the app. The software appimplements the tare weight. Implement a terminal version of the programor add to app. Calibration data is stored in the cap device, or storedin the cloud for future reference, or to understand if offset changesover time. In non-volatile memory, the calibration data is uploaded to acloud server. Sending the calibration data to the app to verify properassembly and calibration. The medicine type is either read by a scanningdevice or written into the software app. The cap device knows the kindof medicine by either a medical ID code, a field to fill in by the user,or a QR code scanned to identify the medicine type. The software versionis written by the programming/calibration app and read by the usesoftware app. The cap includes its configuration so the app knows whichversion it is talking with for future versions. Requires Interfacedocument to be updated and support added by the app. At initial patientusage, when medication is entered: starts data capture, TX/RX parametersare bumped to “active mode”; the sound indicator is activated. The capdevice converts from “shipping mode” to “active mode” when going to beused by the patient. After calibration device is put in standby modewith only BT working infrequently until Medicine ID is entered user. Thecap device conserves battery life until ready to be used by the patient.Medicine ID is wiped during calibration. A factory medicine ID may beused.

Data is saved to External Memory. If a patient doesn't connect to aphone for several days, the cap device stores all collected data untilupload via BLE is possible. Sound annunciator is turned off with thefollowing events: app, shake cap, turn upside down, 10 second timer×10sec break 3 times. The audible annunciator does not run all the time bya fail-safe check.

The load cell resolution meets the requirement of about 0.05 g. Theaccuracy of the load cell is determined through calibration and errorcorrection. Using simple 2-point calibration (linear, with zero offsetand slope), the maximum error is about 0.162 g. Accuracy can further beincreased with multipoint stepwise, linear calibration, or non-linearcalibration. The load cell comprises an absolute accuracy andrepeatability better than 0.05 g, absolute accuracy can fluctuate overthe weight applied (i.e. from about 0-about 100 g)

System

As used in this application, the terms “component” and “system” areintended to refer to a computer-related entity, either hardware, acombination of hardware and software, software, or software inexecution. For example, a component can be, but is not limited to being,a process running on a processor, a processor, an object, an executable,a thread of execution, a program, and/or a computer. By way ofillustration, both an application running on a server and the server canbe a component. One or more components can reside within a processand/or thread of execution, and a component can be localized on onecomputer and/or distributed between two or more computers.

Generally, program modules include routines, programs, components, datastructures, etc., that perform particular tasks or implement particularabstract data types. Moreover, those skilled in the art will appreciatethat the inventive methods can be practiced with other computer systemconfigurations, including single-processor or multiprocessor computersystems, minicomputers, mainframe computers, as well as personalcomputers, hand-held computing devices, microprocessor-based orprogrammable consumer electronics, and the like, each of which can beoperatively coupled to one or more associated devices.

The illustrated aspects of the innovation may also be practiced indistributed computing environments where certain tasks are performed byremote processing devices that are linked through a communicationsnetwork. In a distributed computing environment, program modules can belocated in both local and remote memory storage devices.

A computer typically includes a variety of computer-readable media.Computer-readable media can be any available media that can be accessedby the computer and includes both volatile and nonvolatile media,removable and non-removable media. By way of example, and notlimitation, computer-readable media can comprise computer storage mediaand communication media. Computer storage media includes volatile andnonvolatile, removable and non-removable media implemented in any methodor technology for storage of information such as computer-readableinstructions, data structures, program modules or other data. Computerstorage media includes, but is not limited to, RAM, ROM, EEPROM, flashmemory or other memory technology, CD-ROM, digital versatile disk (DVD)or other optical disk storage, magnetic cassettes, magnetic tape,magnetic disk storage or other magnetic storage devices, or any othermedium which can be used to store the information signal and which canbe accessed by the computer.

Communication media typically embodies computer-readable instructions,data structures, program modules or other data in a modulated datasignal such as a carrier wave or other transport mechanism, and includesany information delivery media. The term “modulated data signal” means asignal that has one or more of its characteristics set or changed insuch a manner as to encode information in the signal. By way of example,and not limitation, communication media includes wired media such as awired network or direct-wired connection, and wireless media such asacoustic, RF, infrared and other wireless media. Combinations of the anyof the above should also be included within the scope ofcomputer-readable media.

Software includes applications and algorithms. Software may beimplemented in a smart phone, tablet, or personal computer, in thecloud, on a wearable device, or other computing or processing device.Software may include logs, journals, tables, games, recordings,communications, SMS messages, Web sites, charts, interactive tools,social networks, VOIP (Voice Over Internet Protocol), e-mails, andvideos.

In some embodiments, some or all of the functions or process(es)described herein and performed by a computer program that is formed fromcomputer readable program code and that is embodied in a computerreadable medium. The phrase “computer readable program code” includesany type of computer code, including source code, object code,executable code, firmware, software, etc. The phrase “computer readablemedium” includes any type of medium capable of being accessed by acomputer, such as read only memory (ROM), random access memory (RAM), ahard disk drive, a compact disc (CD), a digital video disc (DVD), or anyother type of memory.

All publications and patent applications mentioned in this specificationare herein incorporated by reference to the same extent as if eachindividual publication or patent application was specifically andindividually indicated to be incorporated by reference.

While the invention has been described in connection with variousembodiments, it will be understood that the invention is capable offurther modifications. This application is intended to cover anyvariations, uses or adaptations of the invention following, in general,the principles of the invention, and including such departures from thepresent disclosure as, within the known and customary practice withinthe art to which the invention pertains.

What is claimed is:
 1. A medication adherence apparatus comprising: acontainer element operably coupled to a cap device; the cap deviceobtains a weight of the container element, an orientation of the capdevice, a temperature of the cap device, and a time stamp including aday, time, and date; wherein the weight of the container element isobtained when the container element is inserted into the cap device; aconnection of the container element in the cap device is detected by thecap device; the orientation of the cap device is detected to determineif the cap device and the container element is upright generally along avertical axis; any movements along the vertical axis, a longitudinalaxis, or a lateral axis are detected; and the cap device receives amedication schedule and notification parameters to notify a patient byan alarm if medication is missed; wherein the alarm is selected from agroup consisting of: an audio sound, a visual notification, anelectronic notification, or a cell phone notification; wherein thecontainer element is selected from a group consisting of: an ointmenttube, wide-mouthed plastic jar, or a platform developed for storage,display, and utilization of medicament container selected from a groupconsisting of: a tube, pill bottle, balm jar, and tray; wherein thecontainer element houses a medication selected from the group consistingof: pill, powder, liquid, or gas form; a hardware system combiningsensors to record an orientation, temperature, time stamp, and locationof the cap device and the hardware system operably coupled to a mobiledevice or a computing device; wherein the hardware sends an informationsignal to a mobile application or a server; wherein the cap devicecomprises a PCB, a first main housing, a first battery cover, a firstspacer cap, a battery, a load cell, a bottom stop cap, alight pipe, anda base cap, a Surface Mount Transducer; and a plurality of screws; theload cell detects a movement and connection of the cap device to thecontainer element; and a detection signal is sent to a remote module tonotify a user if the cap device is secured to the container element andnotifies a program or module every time the cap device is removed orsecured to the container element; wherein the battery is operablydisposed in the first battery cover is operably disposed over the PCB;the first battery cover is operably coupled with the first spacer cap;the first spacer cap is operably coupled with the light pipe and isoperably disposed over the PCB; a first screw and a second screw securesthe first main housing to the first spacer cap; the PCB is operablycoupled with the Surface Mount Transducer and the PCB is operablydisposed with the load cell; and the load cell is operably disposed onthe base cap.
 2. A method of adhering to medical prescriptionrequirements; comprising: combining sensors and hardware to record a capstate including an orientation, temperature, time stamp, and location ofa cap device to enhance a patient's adherence to medical prescriptionwhen operably coupled with a mobile device or other computing device;sending a cap state information signal to a mobile application or aserver; a) checking a cap device state; b) if a state of the cap devicehas changed in step a, then the cap device determines if the cap deviceis on or off a container element; c) if the cap device is off, then thecap device creates a dataset comprising a timestamp, a state of the capdevice, an orientation of the cap device, and a temperature of the capdevice; d) if the cap device is on, then the cap device checks theorientation; e) after step d, the cap device checks the orientation ofthe cap device and determines if the cap device is upright along avertical direction; f) if the cap device is not upright, the methodadhering to medical prescription reverts back to step e to check theorientation of the cap device; g) if the cap device is not upright afterchecking the orientation of the cap device at least 5 times, then step ccreates the dataset with the timestamp, the state of the cap device, theorientation of the cap device, a weight of the container element, andthe temperature of the cap device; h) if the cap device is upright, thecap device measures the weight of the container element; i) creating adataset with a timestamp, a state of the cap device, the orientation ofthe cap device, the weight of the container element, and the temperatureof the cap device; and j) after both step e and step i proceed back tostep a to check the cap device state.
 3. The method of claim 2, furthercomprising waking up an accelerometer to determine if the cap device isupright; detecting when the container element is off the cap device by aproximity sensor and saving Cap off event to a memory storage and goinginto an Idle-mode with low power requirements; detecting the cap deviceis on the container element, and waking up an Analog-Digital-Converter(ADC) to measure weight by a load cell; checking an accelerometer for nomovement and proper orientation and if the cap device is not upright,then the cap device warns patient through indicators and checks theaccelerometer for no movement and proper orientation; saving a Cap onevent with invalid weight to memory if the cap device is not upright,sounding an alarm and going back to the Idle-mode; Initiating a weightmeasurement if the cap device is upright and still with no movement, theADC takes a plurality of weight-measurements while watchingaccelerometer and proximity sensors; Warning a user with an alarm if aweight measurement process is disrupted by movements or detecting thecap device is off from the container element, and initiating the weightmeasurement after a period of time; Saving a Cap on event with invalidweight to the memory storage, sounding an alarm, and going back to theIdle-mode if at least three weight measurements tries are disrupted; andSaving a Cap on event with valid weight to memory, sounding a positiveindication; and going to the Idle-mode if a plurality of weightmeasurements are taken without disruption.
 4. The method of claim 3,further comprising a Reminder-Functionality operation where a softwareapplication sends times of adherences to the cap device; if medicationwas taken by registering a difference in the weight of the containerelement, then the cap device initiates a positive indicator a timeperiod before adherence; and on time of scheduled adherence, and the capdevice initiates an alarm after adherence if the medication was nottaken by measuring a same weight of the container element a time periodafter scheduled medication time.
 5. A method of adhering to medicalprescription requirements; comprising a) Tracking parameters with a capdevice that tracks selected from the group consisting of: an amount ofmedication dispensed, a temperature at medication dispensation, a timeat medication dispensation; b) Receiving a plurality of trackingparameters with a software module and the software module communicatingwith the cap device using a data protocol; and c) Storing the pluralityof tracking parameters in a server database thereon for storingadherence data (Web System) and the server database communicates withsoftware module for the tracking parameters upload and download; whereinthe data protocol is a low power Bluetooth (BLE) and the server databaseusing a WiFi or cellular network; the software module determines if apatient is taking a medicine based on Tracking parameters from the capdevice and produce local alarms based on an established protocol; thesoftware module provides additional adherence reporting capabilities andfacilitate surveys of the patient; the software module checks on a lastdata sync timestamp with the cap device for each BLE connectionestablished and pulls in all available data from the cap device; and thesoftware module transits this data back to the server database andreceive data and tracking parameters from the server database; whereinthe plurality of tracking parameters include: whether medication isapplied or not applied, time when medication is applied, and quantity ofmedication applied during each dose; wherein the server databaseincludes database systems that store a medication adherence data from acollection of patients, and software code for predictive algorithms thatcan predict patient adherence trends from a collected data, stratifypatient behavior based on adherence data and survey results, anddetermine suitable messages to be provided to a Mobile Application toimprove patient adherence; and gathering data from all patients to modelpatient behavior with respect to skipping medications and othernon-adherence trends.
 6. The method of claim 5, wherein the serverdatabase includes an Administrative Web Portal to manage patientsparticipating in a trial, a medication schedule specific to a trial,setting up surveys and data reports, and providing medication adherencereporting.
 7. The method of claim 6, wherein the server database andsoftware module includes a plurality of data security layers, passwordprotection and encryption of data occurs at every level.